Monthly vascular bulletin — October 19, 2026

Colleagues: this issue covers October 13 to 19, 2026, the week after the previous issue. It was a post-congress week: nearly everything comes from the VIVA and The VEINS 2026 sessions (Las Vegas), whose data reached the specialty press between October 13 and 16, plus two FDA authorizations announced by their manufacturers. The venous block has six items, including a pivotal trial of aspiration thrombectomy for acute iliofemoral deep vein thrombosis. Ten items in all; two fall outside the strict period and are flagged.

Peripheral arterial disease

1. ELEGANCE registry: 93% primary patency at 12 months with the Eluvia drug-eluting stent in complex femoropopliteal lesions

[Congress] [United States]
Analysis of 382 patients (405 femoropopliteal lesions) treated with the paclitaxel-eluting Eluvia stent (Boston Scientific) in the prospective ELEGANCE registry, which focuses on populations historically underrepresented in trials. The cohort was complex: 61.5% chronic total occlusions, 63.9% moderate to severe calcification, 33.3% lesions 150 mm or longer, 55.7% diabetics and 36.2% with chronic limb-threatening ischemia (Rutherford 4 to 6). At 12 months (Kaplan-Meier): primary patency 93.2%, freedom from clinically driven target lesion revascularization 94.1% and freedom from major amputation 99.4%; in the most complex subgroups patency held between 93.6% and 94.2%. Presented by Eric Secemsky in the late-breaking trials session at VIVA 2026 and reported by Endovascular Today on October 16.
Why it matters: these are very good numbers for difficult anatomy, but this is a single-arm, manufacturer-sponsored registry with no comparator and the selection bias inherent to participating centers; it confirms that the drug-eluting stent performs well outside pivotal trials, not that it should be chosen over drug-coated balloons or atherectomy.
https://evtoday.com/news/elegance-registry-reports-12-month-eluvia-des-outcomes-in-complex-pad

2. Screening, legislation and artificial intelligence to close the gaps in peripheral artery disease care (VIVA 2026 session)

[Congress] [United States]
TCTMD report (October 15) on a VIVA session about underdetection and undertreatment of peripheral artery disease. Highlights: only about half of patients receive full guideline-directed medical therapy after a peripheral intervention; in California, 6.4 million residents live in regions with no vascular providers, and in the community screening program CHAMPIONS 30% had undiagnosed diabetes, 38% undiagnosed hypertension and 21% intermittent claudication. The AID-PAD study (7,800 patients) starts in October 2026 and will combine electronic health records and machine learning to automatically flag patients with vascular disease; the session also cited the Illinois law (2025) requiring insurers to cover annual PAD screening for at-risk individuals.
Why it matters: this is not a study but a congress session with observational data and local programs; its value is agenda-setting (the medical-therapy gap is real and measurable), and studies such as PAD-ALERT, which will compare alert-based decision support with standard care, are worth following before assuming that electronic alerts change clinical outcomes.
https://www.tctmd.com/news/screening-legislation-and-ai-may-help-close-gaps-pad-care

Venous disease

3. BOLT-DVT: computer-assisted vacuum thrombectomy as first-line treatment for acute iliofemoral deep vein thrombosis

[Clinical trial] [United States]
Prospective, multicenter pivotal investigational device exemption study (NCT05003843), sponsored by Penumbra, of 229 patients at 39 US sites (mean age 58 years, 62% women) treated with the Indigo system. Both primary endpoints were met: thrombus reduction of 75% or more in the target segment in 98% of evaluable patients (198 of 202; median reduction 100%) and a 48-hour major adverse event rate of 3.1% (7 of 229: major bleeding 1.3%, symptomatic pulmonary embolism 0.9%, rethrombosis 1.3%), with no device-related deaths or serious device-related events. Device time 18 minutes, single-session completion in 99.1%, 30-day major adverse events 7.6%, 30-day rethrombosis 3.9%, and the Villalta score fell from 11 to 1 at 30 days. Presented by Patrick Muck at VIVA 2026; follow-up planned through two years.
Why it matters: this is a pivotal trial with good 48-hour safety results, but it is single-arm, manufacturer-sponsored, with an anatomic (not clinical) efficacy endpoint and very short follow-up; the question that matters, whether it prevents post-thrombotic syndrome compared with anticoagulation alone, remains without a randomized answer after ATTRACT and CAVA.
https://evtoday.com/news/bolt-dvt-evaluates-cavt-with-penumbras-indigo-aspiration-system

4. Recana (InterVene): mechanical thrombectomy for venous in-stent restenosis and chronic residual venous obstruction

[Congress] [United States] [United Kingdom]
Prospective, multicenter study presented by Stephen Black at The VEINS 2026 (reported October 13) in patients with symptomatic chronic venous disease (CEAP C3 or higher, or pain) and flow-limiting obstruction greater than 50% in the IVC, iliocaval confluence, femoral, popliteal or inflow segments, with or without prior stents. Primary endpoint: effective diameter of at least 50% at procedure completion by intravascular ultrasound. Results: patency in 96.2% of target limbs, mean lumen area from 12.5 to 92.7 mm² per segment (about 7.4-fold), 107-minute procedures, 1.4-day stay; all interventions completed in a single session under general anesthesia. The report does not state the number of patients or complications.
Why it matters: it addresses an orphan problem (the occluded venous stent or post-thrombotic fibrotic tissue that does not respond to angioplasty), but with a purely anatomic and immediate endpoint, no published n, no adverse events and no mid-term patency; the full publication must be seen before any adoption.
https://evtoday.com/news/intervenes-recana-thrombectomy-system-studied-for-venous-isr-and-rvo

5. Abre venous stent surveillance registry (Medtronic): first 151 patients at 30 days

[Industry] [Congress] [United States] [Europe]
Early data from the Product Surveillance Registry (NCT01524276), Medtronic's prospective global postmarket platform, presented by Paul Gagne at The VEINS 2026: 151 patients with at least one Abre stent for iliofemoral venous outflow obstruction at 15 sites in Europe and the United States (June 2024 to September 2025), 72.8% women, mean age 50.6 years. At 30 days: no stent fractures, one target lesion revascularization (0.7%) and a significant decrease in pain; patients with 18 to 20 mm stents had greater immediate pain, which returned to overall-cohort levels by day 30. Patency and major adverse events are not reported; primary endpoints (fracture and revascularization) run to 60 months.
Why it matters: at 30 days a venous stent registry can report little beyond technical safety, and that is what it does; the post-procedural pain data by diameter are clinically useful for counseling patients, but 1- and 5-year patency, which is what distinguishes a venous stent, is still to come.
https://evtoday.com/news/early-data-presented-from-real-world-registry-of-medtronics-abre-venous-stent-system

6. RAPID-PE: mechanically channeled thrombolysis (Thrombolex) in intermediate-risk pulmonary embolism, interim analysis of 150 patients

[Congress] [United States]
Prospective, multicenter, single-arm postmarket study (NCT06433011) of the Thrombolex device, with thrombolytic delivered on the table during the same procedure; interim analysis of the first 150 of 350 planned patients at 20 US sites with 45 operators, presented by Wissam Jaber at The VEINS 2026. Procedural success 100% (150 of 150); all-cause mortality or hemodynamic decompensation through 7 days 0.7% (1 of 150); major bleeding within 72 hours 0.7% (1 of 150); no strokes or device-related deaths through 30 days; 90% required no post-procedure intensive care. The CT angiography substudy of RV/LV ratio and subsegmental clearance is expected to be completed in 2027, according to the company.
Why it matters: a 0.7% major bleeding rate with a thrombolytic is striking and the 90% avoidance of ICU admission has an economic reading, but this is an interim analysis with no comparator, no hemodynamic data (the RV/LV ratio is pending), manufacturer sponsorship and less than half of the planned sample; against HI-PEITHO and PEERLESS it does not yet allow the technique to be positioned.
https://evtoday.com/news/thrombolex-device-for-mechanically-channeled-thrombolysis-evaluated-in-rapid-pe

7. FDA clears (510(k)) the Hēlo thrombectomy system and the Hēlo Return blood return system (Endovascular Engineering) for pulmonary embolism and venous vasculature

[Regulatory FDA] [United States] [Outside the period: October 12]
Endovascular Engineering (E2, Menlo Park, California) announced on October 12 two 510(k) clearances: the Hēlo system, indicated for non-surgical removal of emboli and thrombi from the pulmonary arteries and venous vasculature (15 Fr profile, steerable navigation, 24 Fr clot ingestion funnel, continuous aspiration with mechanical disruption), and Hēlo Return, which the company describes as the first blood return system cleared for use with continuous vacuum aspiration, and which collects and filters aspirated blood and returns it to the patient. The press release cites the ENGULF IDE study and "near-zero blood loss," with blood-return results in 40 patients, but publishes no figures for clot reduction, blood loss or adverse events; it claims "the highest reported clot reduction and the lowest estimated blood loss" across PE IDE studies, and states in a footnote that this is a descriptive cross-study comparison, not a head-to-head one.
Why it matters: integrated blood return addresses a real limitation of large-bore aspiration in pulmonary embolism, but the 510(k) pathway establishes substantial equivalence, not superiority, and the comparative claims in the release are the manufacturer's, without verifiable public figures; the ENGULF publication is worth waiting for.
https://www.prnewswire.com/news-releases/e2-secures-dual-fda-clearances-for-the-hlo-platform-introducing-a-pe-thrombectomy-system-with-integrated-blood-return-302905960.html
https://evtoday.com/news/fda-clears-e2-helo-thrombectomy-system-and-integrated-blood-return-system

8. Veinsound starts its first-in-human study of AI-guided focused ultrasound to occlude the great saphenous vein without a catheter

[Industry] [Romania]
Veinsound announced (Venous News, October 13) the start of EASY-VEIN NT, the first-in-human study of its "AI-focused ultrasound" to treat chronic venous insufficiency and varicose veins; according to its CEO, treatment is done in the office, without heat, needles or catheters, and without anesthesia. Design: a safety cohort followed by a performance group, at Sanconfind Medical Center in Câmpina, Romania, with Zoltan Galajda as principal investigator and René Milleret as co-investigator. Four patients treated to date, sessions under 12 minutes along the saphenous vein, procedures described as complication-free and "occlusion and wall remodeling" observed at one week. No planned n, formal endpoints or quantitative data are published.
Why it matters: transcutaneous saphenous occlusion without venous access would be a relevant alternative to thermal and non-thermal ablation, but here there are only company and investigator statements about four patients, no cited trial registration, no defined occlusion criteria and no follow-up; it is news to watch, not to change practice.
https://venousnews.com/veinsound-launches-easy-vein-nt/

Aorta

9. FDA approves expanded indication for the Gore Viabahn VBX as a bridging stent in FEVAR and BEVAR

[Regulatory FDA] [United States]
W. L. Gore announced on October 14 FDA approval to use the Viabahn VBX balloon-expandable endoprosthesis as a bridging stent to maintain visceral artery perfusion in fenestrated (6 to 8 mm fenestrations) and branched (6 to 8 mm branches at least 10 mm long) endovascular aneurysm repair, limited to aortic endograft systems with demonstrated safety and effectiveness. It rests on three-year results of the multicenter, core-lab-analyzed EMBRACE registry presented at the ESVS meeting (Belgrade, October 6 to 9): in FEVAR (103 patients, 208 target vessels) primary patency 97.5% and freedom from target vessel instability 93.9%; in BEVAR (165 patients, 454 vessels) 94.0% and 88.4%, respectively. The equivalent indication has held CE mark since 2025.
Why it matters: according to Gore, it is the first bridging stent with an on-label indication for both FEVAR and BEVAR in the United States; the EMBRACE registry is single-arm and manufacturer-run, and the 88.4% three-year freedom from target vessel instability in BEVAR is a reminder that the Achilles heel of complex repair is still the bridging vessel.
https://www.goremedical.com/about-us/news/fda-approves-vbx-fevar-bevar
https://vascularnews.com/us-fda-approves-gore-viabahn-vbx-balloon-expandable-endoprosthesis-for-expanded-use-in-fevar-and-bevar/

10. Rural patients with abdominal aortic aneurysm: larger aneurysms, more urgent presentations and more loss to follow-up after EVAR (VQI, 62,503 patients)

[Publication] [United States] [Outside the period: October 12]
Analysis of the EVAR module of the SVS Vascular Quality Initiative published online in the Journal of Vascular Surgery and reported by TCTMD on October 12 (Inkollu, Minc and colleagues): 62,503 patients treated between 2003 and 2021, 21% from rural areas. Rural patients were more often current smokers (37% vs 31%) and had COPD more often (37% vs 33%), and between 9 and 21 months after the procedure had higher mortality (7.8% vs 6.8%, unadjusted). Adjusted for sociodemographics, comorbidities and procedural differences, rural residence was associated, among men, with aneurysms larger than 6.5 cm (OR 1.09; 95% CI 1.03 to 1.15) and, overall, with urgent presentation (OR 1.18; 1.11 to 1.24), loss to follow-up between 9 and 21 months (OR 1.14) and lower odds of in-person follow-up (OR 0.90; 0.86 to 0.95).
Why it matters: it is observational, zip-code based and limited to those who reached repair, but with an enormous sample it quantifies two problems also present in our settings: late diagnosis and lost follow-up after EVAR; the authors propose more ultrasound machines in rural clinics, training of vascular technologists and mobile screening, and the senior author also suggests telemedicine surveillance.
https://www.tctmd.com/news/pre-and-post-evar-care-not-optimal-rural-aaa-patients

Upcoming meetings and dates

• DFCon (diabetic foot), Anaheim, California: October 22 to 24.
• AMP Europe (amputation and peripheral disease), Amsterdam: October 26 to 28.
• CiDA, Controversies in Dialysis Access, Washington, DC: October 29 to 31.
• TCT 2026, San Diego: October 31 to November 3.
• SILAN 2026, Guadalajara, Mexico: November 4 to 7.
• AHA Scientific Sessions 2026, Chicago: November 6 to 9.
• Venous Symposium Europe 2026, Athens: November 12 to 14.
• VEITHsymposium, New York: November 17 to 21.

Vascular bulletin — October 19, 2026
Ten verified items, mostly from VIVA and The VEINS 2026:
• BOLT-DVT (n = 229, 39 sites): Indigo aspiration thrombectomy in acute iliofemoral DVT; ≥ 75% thrombus reduction in 98% of evaluable patients and 48-hour major adverse events of 3.1%. Single-arm, anatomic endpoint, short follow-up.
• FDA approves the Gore Viabahn VBX as a bridging stent in FEVAR and BEVAR: 3-year primary patency of 97.5% and 94.0% (EMBRACE registry, single-arm).
• ELEGANCE registry (n = 382): Eluvia stent in complex femoropopliteal disease, 93.2% primary patency at 12 months with 61.5% chronic total occlusions. No comparator.
Also: Recana, Abre, RAPID-PE, Hēlo, Veinsound, gaps in peripheral artery disease care and AAA in rural patients.
Full bulletin:
https://boletinesmedicos.com/en/vascular/2026-10-19.html

Vascular bulletin — October 19, 2026
Ten verified items from the week of October 13 to 19 (two of them from October 12, flagged), drawn from VIVA and The VEINS 2026, the Journal of Vascular Surgery, Endovascular Today, TCTMD, Venous News, Vascular News and official manufacturer communications.
Three worth your time:
• BOLT-DVT (n = 229, 39 sites): Indigo aspiration thrombectomy in acute iliofemoral DVT, ≥ 75% thrombus reduction in 98% of evaluable patients and 48-hour major adverse events of 3.1%. Single-arm, anatomic endpoint, short follow-up.
• FDA approves the Gore Viabahn VBX as a bridging stent in FEVAR and BEVAR: 3-year primary patency of 97.5% and 94.0% (EMBRACE). Single-arm manufacturer registry; freedom from target vessel instability of 88.4% in BEVAR.
• ELEGANCE registry (n = 382): Eluvia stent in complex femoropopliteal disease, 93.2% primary patency at 12 months with 61.5% chronic total occlusions. No comparator.
Full bulletin, with a critical reading of each study and links to its sources:
https://boletinesmedicos.com/en/vascular/2026-10-19.html
#VascularSurgery #Endovascular #VenousDisease #DVT #Aorta

BOLT-DVT: aspiration thrombectomy in iliofemoral DVT (n=229), ≥75% thrombus reduction in 98% of evaluable patients, 48-h major adverse events 3.1%. FDA approves Gore VBX as bridging stent in FEVAR/BEVAR (3-year patency 97.5%/94.0%).
https://boletinesmedicos.com/en/vascular/2026-10-19.html